FDA.reportPublic FDA data

NDC 68071-4375-05 - Neomycin Polymyxin B Sulfates and Dexamethasone

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68071-4375
Requested NDC
68071-4375-05
Package NDCs from labels
68071-4375-5, 68071-4375-05
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-06-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Neomycin Polymyxin B Sulfates and Dexamethasone - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2024-06-07HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-06-15Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP (Sterile)
2023-01-30Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP (Sterile)
2021-02-16Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP (Sterile)
2021-01-29Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4375-5Neomycin Polymyxin B Sulfates and Dexamethasone5 mL in 1 BOXSUSPENSION/ DROPS57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4375NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [NUCARE PHARMACEUTICALS,INC.]7Current NDC, Legacy NDC, 1 package rows20240608_691bc5ca-5d61-60c2-e053-2991aa0abb93.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 91 of 134 · 2,662 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MARVEL BZK ANTISEPTIC WIPEBENZALKONIUM CHLORIDEAshtel Studios, Inc.93ed0bb4-834d-44ca-9c0a-20086fc09ab82024-11-18WarningsExact identifier
unii: F5UM2KM3W7
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEA-S Medication Solutions84d32193-c2cc-4837-88d1-c7d7dc2c70422024-11-18Warnings, Adverse reactionsExact identifier
unii: 057Y626693
unii: 19371312D4
First Aid Only First Aid/BurnLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEAcme United Corporationcaa67a05-bdbd-c380-e053-2995a90a0bf12024-11-17WarningsExact identifier
unii: F5UM2KM3W7
Altra Non-Alcohol Foaming Hand Sanitizer with Allantoin and AloeBENZALKONIUM CHLORIDEBuckeye International, Inc.a35ad6ce-700c-5b42-e053-2995a90a7da62024-11-15WarningsExact identifier
unii: F5UM2KM3W7
SYMMETRY ANTIMICROBIAL FOAMING HAND WASH w/Benzalkonium ChlorideBENZALKONIUM CHLORIDEBuckeye International, Inc.e2891cfb-9664-bd02-e053-2995a90ab8d12024-11-15WarningsExact identifier
unii: F5UM2KM3W7
Symmetry Non-Alcohol Foaming Hand Sanitizer with Allantoin and AloeBENZALKONIUM CHLORIDEBuckeye International, Inc.2750f62c-e650-428a-b070-5c13ff8e378e2024-11-15Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Neosporin OriginalBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEKenvue Brands LLCf07d3bca-4312-46ed-b0c4-f886c01bd0952024-11-14WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
Polysporin First Aid AntibioticBACITRACIN ZINC AND POLYMYXIN B SULFATEKenvue Brands LLCe0fcf83e-a374-4fc0-a629-8730330543922024-11-14WarningsExact identifier
unii: 19371312D4
Antiseptic ToweletteBENZALKONIUM CHLORIDEUNCHARTED SUPPLY COMPANY, INC.25840eb7-9317-439f-a8e8-a7d889c060d22024-11-14WarningsExact identifier
unii: F5UM2KM3W7
Neosporin Pain Itch ScarBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC55392c48-b5d8-44cd-8c10-6d86683498482024-11-13WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
Neosporin Kids Plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC6752f0a0-2432-4d8b-8198-74ae96a689632024-11-13WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
Neosporin Plus Pain Relief First Aid Antibiotic/Pain RelievingNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC23222e54-d793-4d79-980e-550e32a957422024-11-13WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
Neosporin OriginalBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEKenvue Brands LLCa3e6fe2e-1b74-4f22-9c7c-a000574396902024-11-13WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
Neosporin Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC32302dcd-f3f1-408b-ae5f-e7d8b666f68f2024-11-13WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
NEOSPORIN Plus BURN RELIEFBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC3caa7fd1-bd66-427e-a6c0-1b137b2050892024-11-13WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
Simply Neosporin First Aid AntibioticBACITRACIN ZINC AND POLYMYXIN B SULFATEKenvue Brands LLC68bfecea-095f-4d3f-b077-d86e1b9f1faa2024-11-13WarningsExact identifier
unii: 19371312D4
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Company99a15716-bbb9-4e33-a48d-20c58b81f3922024-11-13Exact identifier
unii: 451W47IQ8X
Triple Antibiotic and Burn ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDECVS Pharmacyfdc510b8-f3ad-4bd6-a8d0-1b81e9f30e132024-11-13WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
TRIPLET ANTIBIOTICTRIPLET ANTIBIOTICALLIED TRADE LINK LLC26bd5ba4-264b-2a28-e063-6394a90ada802024-11-12WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
Itch FormulaANTIPYRINUM, APIS MELLIFICA, CALENDULA OFFICINALIS, CANTHARIS, COPAIVA OFFICINALIS, CROTON TIGLIUM, GRAPHITES, HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, MEZEREUM, NATRUM MURIATICUM, PETROLEUM, RHUS VENENATA, STAPHYSAGRIA, SULPHUR, URTICA URENSDeseret Biologicals, Inc.4dfb177b-bff3-4b6d-8fd9-cadd1df7812c2024-11-12WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.